Trainee - Clinical Development & Medical Affairs
Bengaluru, Karnataka, India
About Immuneel
Immuneel Therapeutics Private Limited is a pioneering start-up company leading the charge in cell therapy and personalized immunotherapy for patients in India. For more details, please refer www.immuneel.com
We Pursue, with Purpose, to serve our Patients (3 Ps) by Connecting within, Collaborating globally and Creating (3 Cs) solutions. Our flexible, diverse, and vibrant team is bringing together best practices and innovations in the field of cell and gene therapy.
Working at Immuneel promises the excitement of an agile start-up on a critical mission. Proudly Indian in solutioning, yet global in outlook, we are keen to collaborate. We value diversity including in experience and perspectives. We value work-life balance and believe that having fun on the job is integral to achieving the right results. We pride ourselves on providing an open environment and our mission resonates with humanity everywhere. At Work, we are:
- Passionate in driving patient outcomes: We are passionately committed to doing the RIGHT thing to achieve the best outcomes for our patients through innovation, agility and performance orientation. We put the impact on the patient above all else.
- Responsible and accountable: We demonstrate ownership and accountability for our actions. We make timely and well-informed decisions, learning from our performance.
- Transparent, honest, and supportive in how we work together: We insist on integrity and respect for the individual. We demand excellence. Our performance management is focused on excellence through timely and constructive feed-forward.
- Inclusive and flexible: We are full of life and embrace all opportunities to collaborate and work together. We are excited about the collective knowledge and expertise that we share. “Being and thinking different” is valued.
Immuneel’s employees are integral to our quest to develop and deliver high quality engineered cell therapies in India. We believe that our culture provides an environment for employees to excel and find purpose. The strength of our team is every bit as important as our cutting-edge technology and we invest in clear compensation and comprehensive benefits for our employees. People for us, are not resources, but our capital.
If you are a talented professional, an out-of-box thinker with a zeal to help change, and passionate about healthcare, we invite you to join us and be a part of a historic initiative in India.
Interested to be a part of the next revolution in cancer treatment? Send your resume to careers@immuneel.com
1. Role Title:
Trainee – Clinical Development & Medical Affairs
2. Department/Function:
Medical Affairs
3. Reporting Structure:
- Reports to: Medical Affairs
- Direct Reports: Individual contributor
4. Role Summary:
The Trainee will support post‑approval safety monitoring activities for advanced therapy medicinal products (ATMPs), including CAR‑T cell and gene therapies. This role is designed to provide structured training and hands‑on exposure to pharmacovigilance, safety reporting, and regulatory compliance in a highly specialized and fast‑evolving therapeutic area
5. Key Responsibilities:
- Assist in collection, review, and documentation of post‑market efficacy and safety data including adverse events (AEs) and serious adverse events (SAEs).
- Support real world data generation and maintenance of case record forms including safety case records in pharmacovigilance databases under supervision.
- Data Analytics including data collection, entry, identifying data gaps and its addressal, analysis and outcome assessments.
- Assist in tracking therapy‑specific safety events such as cytokine release syndrome (CRS), neurotoxicity (ICANS), infections, and other known CAR‑T/CGT risks.
- Support preparation of post‑market reports such as:
- Post‑Market Surveillance Reports (PMSR)
- Periodic Safety Update Reports (PSUR/PBRER)
- Long‑Term Follow‑Up (LTFU) safety documentation
- Support maintenance of PMS‑related documentation in compliance with internal SOPs.
- Participate in internal training programs related to pharmacovigilance, CGT products, and regulatory compliance.
- Assist in SOP review and documentation updates as assigned.
6. Primary Objectives:
- Compliance to regulatory requirements for PMS
- Signal detection and reporting
7. Competencies Required:
- Technical Competencies:Basic understanding of pharmacovigilance and drug safety concepts.
- Strong attention to detail and documentation skills.
- Good written and verbal communication abilities.
- Willingness to learn complex therapy platforms and evolving regulatory standards.
- Ability to work collaboratively in a regulated environment.
- Soft Skills: Attention to Detail
- Time Management
- Communication Skills
- Cross-functional collaboration
- Accountability for the task
- Compliance to applicable SOPs/guidelines
- Analytical thinking
- Learning agility
- Willingness to learn
- Continuous learning mindset
8. Qualifications:
- Bachelor’s or Master’s degree in Pharmacy, Life Sciences, Biotechnology, Biomedical Sciences, or a related discipline.
- Candidates with specialization or coursework in oncology, immunology, gene therapy, or pharmacovigilance are preferred.
9. Working Conditions:
- Role Type: Full Time and Onsite
- Work Hours: 9:00 AM to 6:00 PM for the General Shift and 2:00 PM to 11:00 PM for the Post-Noon Shift (on a rotational basis). There will be two days off each week, which may not necessarily fall on a Saturday or Sunday.
- Travel Requirements: Yes and 10% of travel
- Base Location: Immuneel Therapeutics Private Limited, 8th Floor, Mazumdar Shaw Medical Center, Narayana Health City, Bommasandra Industrial Area, Bangalore - 560099